14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LORENZ SELF DRILLING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450675106·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033545003·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033544983·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033544990·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033545010·
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
FDA 510(k)
FDA Class 2
·Cardiovascular
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MPRI·Product code DTB·March 21, 2013
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
CHARLOTTE SNAP-OFF SCREW
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·March 12, 2008
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·April 29, 2020
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012